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National Cancer Drugs Fund Application Form – Cetuximab for Metastatic Colorectal Cancer (1st Line in Combination with oxaliplatin-based chemotherapy) Author(s) David Thomson Owner Chemotherapy Clinical Reference Group Version Control Version Control Date Revision summary Ver3.0 14 Jul 2014 Introduction of version control and addition of section re-SACT and monitoring Ver3.1 07 Sep 2015 Update following national CDF panel meeting Change to current version Criteria Changes 5 Now states “Given with oxaliplatin-based combination chemotherapy regimens” Note Removal of note limiting use with other oxaliplatin-based regimens, irinotecanbased combinations or upfront single agent fluoropyrimidine Title Now states “1st Line in combination with oxaliplatin-based chemotherapy” National Cancer Drugs Fund – Application Form 07 Sept 2015 Cetuximab for Metastatic Colorectal Cancer 1st Line in Combination with oxaliplatin-based chemotherapy Page 1 National Cancer Drugs Fund Application Form – Cetuximab for Metastatic Colorectal Cancer (1st Line in Combination with oxaliplatin-based chemotherapy) Instructions to Consultants: Please fill in each section of the form electronically and save the document with your own file name. [If you continue typing the boxes will enlarge to contain the text]. Please send electronically to ______________________. Please also send copies to your Trust’s link accountant / corporate contracting team. Security of Patient Identifiable Information: The patient will be identified by their NHS number only. Please do not include any other patient identifiers for confidentiality reasons. All communication must be sent to the Cancer Drugs Fund Office via secure e mail accounts: that is from an nhs.net account to the ____________ account. Receipt of Application: The sender of the application will receive an acknowledgement, together with details of the unique Cancer Drugs Fund reference. Cancer Drugs Fund Policy: To check the status of a particular therapy please check the Cancer Drugs Fund Policy at _________________ Applications will be subject to Clinical Audit arrangements. BY TICKING THESE BOXES AND SUBMITTING THE APPLICATION THE CLINICIAN IS CONFIRMING THE PATIENT MEETS ALL THE CRITERIA BELOW. IT SHOULD BE NOTED THAT THE SACT DATASET WILL BE USED TO MONITOR THAT THESE CRITERIA ARE BEING MET. Approved Treatment Required for Cetuximab for Metastatic Colorectal Cancer – 1st Line in Combination with oxaliplatin-based chemotherapy TICK All 8 conditions must be met 1. Application made by and first cycle of systemic anti-cancer therapy to be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy 2. Metastatic colorectal cancer 3. 1st line indication 4. Patients with wild-type RAS 5. Given in combination with oxaliplatin-based chemotherapy regimens 6. Cetuximab given as a 2-weekly regimen at a dose of 500mg/m 2 7. a. Not eligible for NICE TA176 approved indications OR Or b. Eligible for treatment under TA176 and no progression after receiving the approved 16 weeks treatment with cetuximab but unsuitable for surgery and meeting criteria 1-6 8. No previous treatment with Cetuximab or Panitumumab (unless meeting condition National Cancer Drugs Fund – Application Form 07 Sept 2015 Cetuximab for Metastatic Colorectal Cancer 1st Line in Combination with oxaliplatin-based chemotherapy Page 2 7b) Note: No treatment breaks of more than 4 weeks beyond the expected cycle length are allowed (to allow any toxicity of current therapy to settle or in the case of intercurrent comorbidities) Note: If excessive toxicity with oxaliplatin, cetuximab can be continued with a fluoropyrimidine alone until disease progression only. Consultant Approval (email authority) Patient Consent Obtained (date of letter – copy to be retained on patient file) National Cancer Drugs Fund – Application Form 07 Sept 2015 Cetuximab for Metastatic Colorectal Cancer 1st Line in Combination with oxaliplatin-based chemotherapy Page 3 Proposed Start Date for Therapy (add clinic date)*: Consultant details* (including signature or email confirmation) Name: Hospital: Address: Post Code: Telephone: Nhs.net Trust Pharmacist details of the Trust where the patient will be treated* Mandatory - NHS No*: Mandatory – Patients date of birth* Optional – Hospital No. Clinical Commissioning Group* Patient’s GP* (name, address, telephone) Name: Hospital: Address: Post Code: Telephone: Nhs.net NHS No: DOB: Hospital No: CCG Name: Name: Address: Post Code: ICD-10 Code (please tick the relevant box)* C18 - Malignant neoplasm of colon C19 - Malignant neoplasm of rectosigmoid junction C20 - Malignant neoplasm of rectum HRG Code Completion of items marked with * is mandatory. Failure to complete these items may mean that payment is not made. National Cancer Drugs Fund – Application Form 07 Sept 2015 Cetuximab for Metastatic Colorectal Cancer 1st Line in Combination with oxaliplatin-based chemotherapy Page 4